Center for Professional Innovation & Education, Inc., Los Angeles, CA
May 5 – 7, 2014
The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. Due to the complexity of today's medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness. By the end of this course, participants will learn how an effective process validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Issues to be covered include: - Assurance of product quality derived from a compliant validation program
- Learn best practices of protocol writing
- Understand the scope of current validation programs, and identify gaps
- Develop Remediation Plans
- Learn how to implement and deploy a Master Validation Plan
- Learn how poor validation procedures and practices can lead to regulatory actions from regulators
Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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